Kua Whiwhi a Penpulimab i te Whakaaetanga NMPA mō te Maimoatanga Tuatahi o te Matepukupuku Nasopharyngeal

I te 16 o Poutū-te-rangi, 2025, i pānuitia e Akeso kua whakaaetia mana e te National Medical Products Administration (NMPA) tana paturopi monoclonal anti-PD-1 auaha, i whakawhanakehia e ia anō, arā, te penpulimab, hei rongoā tuatahi mō te mate pukupuku nasopharyngeal (NPC) e hokihoki mai ana, e horapa mai ana rānei, me te chemotherapy.

Ko te Penpulimab (PD-1 Monoclonal Antibody) i tēnei wā ko te paturopi monoclonal PD-1 kua rerekētia anake e whakamahi ana i te momo IgG1 me te Fc-nulldomain kua whakarerekētia, ka taea te whakarei ake i te whai huatanga o te ārai mate me te whakaiti i ngā urupare kino e pā ana ki te ārai mate. E whakamahia ana hei rongoā i ngā mate nui pēnei i te mate pukupuku pūkahukahu, te lymphoma, te mate pukupuku nasopharyngeal, te mate pukupuku ate, me te mate pukupuku puku, me te haumaru me te whai huatanga kua pai ake e whakaatuhia ana i roto i ngā rangahau haumanu.

Koinei te tohu tuawhā kua whakaaetia mō te penpulimab. Haunga ngā tohu e rua o te NPC, kua whakaaetia hoki te penpulimab mō te maimoatanga tuatahi o te mate pukupuku pūkahukahu squamous non-small cell (NSCLC) kua horapa ā-rohe, kua horapa rānei ina honoa ki te chemotherapy, tae atu ki te monotherapy i roto i ngā tūroro he relapsed, he refractory classical Hodgkin lymphoma (cHL) kua whiwhi i te iti rawa e rua ngā raina chemotherapy pūnaha. Hei tāpiri, kei te arotakehia i tēnei wā he tāpiritanga New Drug Application (sNDA) mō te penpulimab me te anlotinib mō te maimoatanga tuatahi o te hepatocellular carcinoma (HCC) kua horapa.

I mua, i whakaaetia te penpulimab hei rongoā tuatoru mō te NPC matatau. Nā tēnei whakaaetanga hou, ka whakaratohia e te penpulimab te kapinga maimoatanga whānui puta noa i ngā wāhanga katoa o te NPC, e tuku ana i tētahi kōwhiringa ārai mate tonu ki ngā tūroro mai i te rongoā raina tuatahi ki te rongoā raina tuatoru.

I te 19 o Hune, 2024, i whakaputahia e te "Signal Transduction and Targeted Therapy" ngā hua o tētahi rangahau wāhanga II mō te maimoatanga o te mate pukupuku nasopharyngeal metastatic i rongoatia i mua ki te pembrolizumab.

I whakahaerehia tēnei whakamātautau wāhanga tuarua, kotahi te ringa, puta noa i ngā pokapū tiaki tuatoru e 20 i Haina, i whakaurua ngā tūroro pakeke me te mate pukupuku nasopharyngeal metastatic (NPC) kua rahua i ngā raina e rua, neke atu rānei o te chemotherapy pūnaha o mua. I whiwhi ngā tūroro i te 200-mg penpulimab mā te uaua i ia 2 wiki (4 wiki i ia huringa) tae noa ki te whanaketanga o te mate, ki ngā paitini rānei e kore e taea te manawanui. Ko te mutunga tuatahi ko te reiti urupare whāinga (ORR) ia RECIST (putanga 1.1), i aromatawaitia e te komiti arotake radiological motuhake. Ko ngā mutunga tuarua ko te oranga kore-haere (PFS) me te oranga whānui (OS). Kotahi rau toru tekau ngā tūroro i whakaurua, ā, 125 i taea te aromatawai i te whai huatanga. I te rā kati raraunga (Hepetema 28, 2022), kotahi te tūroro i tutuki i te urupare katoa, ā, 34 ngā tūroro i tutuki i te urupare wāhanga. Ko te ORR he 28.0% (95% CI 20.3–36.7%). He roa te urupare, me te 66.8% kei te whakautu tonu i te 9 marama. E toru tekau mā toru ngā tūroro (26.4%) kei te rongoatia tonu. Ko te PFS me te OS toharite he 3.6 marama (95% CI = 1.9–7.3 marama) me te 22.8 marama (95% CI = 17.1 marama ki te kore e tutuki). Tekau (7.6%) ngā tūroro i pāngia e te irAE taumata 3, teitei ake rānei. He pai ngā mahi ārai-pukupuku a Penpulimab me ngā paitini e whakaaetia ana i roto i ngā tūroro NPC metastatic i mua i te maimoatanga nui, e tautoko ana i te whanaketanga haumanu hei maimoatanga tuatoru o te NPC metastatic.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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